The U.S. Food and Drug Administration (FDA) has granted fast track designation to coramitug, an experimental treatment in late-stage clinical testing for transthyretin amyloid cardiomyopathy (ATTR-CM).
The FDA gives this designation to investigational medicines that have the potential to meaningfully improve care for serious health conditions, with the aim of speeding the development of sorely needed new treatments.
The designation gives the therapy’s developer, Novo Nordisk, access to perks such as more frequent communication with the FDA during the development process, and, if certain criteria are met, rolling review and priority review, which provide faster routes to approval. Novo Nordisk is developing coramitug after acquiring rights to the therapy from its original developer, Prothena, in 2021.